This application claims the benefit of U.S. provisional application Ser. No. 60/036,218, filed Jan. 28, 1997.
1. The Field of the Invention
The present invention relates to devices for controlling and regulating urinary incontinence in women.
2. Present State of the Art
Urinary incontinence in women is a relatively common problem which exists in three primary forms. Stress urinary incontinence occurs as a result of physical stress, such as Lifting, coughing, or sneezing. Urge urinary incontinence is a result of gradual loss of control of the nerves that control the micturition process. Mixed urinary incontinence is a combination of symptoms of stress urinary incontinence and urge urinary incontinence.
The problem is often a source of difficulty or embarrassment to the affected woman. One solution, in relatively mild cases, has been the use of pads or diapers to absorb the uncontrolled seepage of urine. This can be undesirable as it sometimes results in restricting the type or style of clothing wished to be worn, as well as requiring frequent changing of absorbent devices. Discomfort and irritation due to the lingering presence of captured urine against tender urogenital tissues is another problem existing with external absorbent systems.
More severe cases require the temporary use of an intraurethral device to control the involuntary seepage or flow of urine. Several devices are known in the prior art for dealing with the problems of urinary incontinence in women. One device comprises a relatively rigid valved catheter having an extendible sealing portion on the interior end of the catheter. The sealing portion must be relatively rigid as it secures the device in the patient and defines at least one aperture to allow the passage of urine into the device. A manually operable valve is located between the internal and external ends of the catheter to enable the woman to selectively control elimination of urine at desired places and times. Other types of valved devices are known, and these generally comprise rigid tubular casings with valves inserted at various locations.
Still other prior art devices comprise solid plugs which are inserted into the urethra to block the involuntary seepage or flow of urine. Several such devices are known in the prior art. As claimed in U.S. Pat. No. 5,082,006, one prior art device comprises a relatively thin, solid shaft having at least one knob or thickening of the shaft along its length. Another device, as claimed in U.S. Pat. No. 5,090,424, comprises a flexible urethral plug which has a soft molded inflatable plastic catheter and a transportable fluid. The device is inserted into the urethra. Pressure applied to an external bellow causes the fluid to be transported into the interior end of the device. The interior or distal end of the device increases in diameter as a result, securely implanting the plug on a temporary basis. Removal is accomplished by deflating the implanted plug.
Most devices employ some kind of enlargement of the interior end of the catheter or shaft to secure the device within the urethra following placement. This can result in discomfort to the woman, and may lead to a sensation of a necessity to void the bladder when it may not be necessary. Additionally, many women suffering from stress urinary incontinence have bladder necks and proximal urethras that will open up during a stress event. This condition exists when the bladder neck becomes deformed from its normally perpendicular state to one which sags downward. When this condition is encountered, securing of the device via an enlarged distal end within the urethra may be negatively affected due to the enlargement occurring at the wrong position on the device.
Further, many prior art devices utilize a form stable catheter or shaft which remains temporarily implanted in the urethra. As a result, the urethra will necessarily be deformed from its normally collapsed configuration which is naturally assumed at all times except during urination, when it will be open. Additional problems, such as bladder and urethral infections may also develop from the extended presence of a relatively rigid artificial body in the urethra, and associated open urethra. The insertion of the rigid device can also transfer bacteria to the bladder.